Dataset Information

Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.

ABSTRACT: BACKGROUND:Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. METHODS/DESIGN:PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month's post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. DISCUSSION:This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. TRIAL REGISTRATION:ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

SUBMITTER: Shafayat A

PROVIDER: S-EPMC6907171 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.

Shafayat Aisha A Csipke Emese E Bradshaw Lucy L Charlesworth Georgina G Day Florence F Leung Phuong P Moniz-Cook Esme E Montgomery Alan A AA Morris Steve S Mountain Gail G Ogollah Reuben R Sprange Kirsty K Yates Lauren L Orrell Martin M

Trials 20191211 1

<h4>Background</h4>Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE interve ...[more]

PMID: 31829232

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Project description:BackgroundWe tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions.MethodsWe conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the 'Join Dementia Research' register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary.ResultsBetween September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention.ConclusionWe conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial.Trial registrationClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

Project description:BackgroundLewy body dementia (LBD) is an aggressive type of dementia of rapid, fluctuating disease trajectory, higher incidence of adverse events, and poorer functional independence than observed in Alzheimer's disease dementia. Non-pharmacological treatments such as progressive, high-intensity exercise are effective in other neurological cohorts but have been scarcely evaluated in LBD.MethodsThe Promoting Independence in Lewy Body Dementia through Exercise (PRIDE) trial was a non-randomised, non-blinded, crossover pilot trial involving older adults with LBD consisting of a baseline assessment, an 8-week wait-list, and an 8-week exercise intervention. The aims of this study were to evaluate the determinants of the primary outcome functional independence, as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale, and the feasibility and preliminary efficacy of an exercise intervention on this outcome. Additionally, important clinical characteristics were evaluated to explore associations and treatment targets. The exercise intervention was supervised, clinic-based, high-intensity progressive resistance training (PRT), challenging balance, and functional exercises, 3 days/week.ResultsNine participants completed the baseline cross-sectional study, of which five had a diagnosis of Parkinson's disease dementia (PDD), and four dementia with Lewy Bodies (DLB). Six completed the exercise intervention (three PDD, three DLB). The cohort was diverse, ranging from mild to severe dementia and living in various residential settings. Greater functional independence at baseline was significantly associated with better physical function, balance, cognition, quality of life, muscle mass ratio, walking endurance, faster walking speed and cadence, and lower dementia severity (p < 0.05). Participants declined by clinically meaningful amounts in functional independence, cognition, physical function, muscle mass, and weight over the wait-list period (p < 0.05). Following exercise, participants improved by clinically meaningful amounts in functional independence, cognition, physical function, and strength (p < 0.05). Progressive, high intensity exercise was well-tolerated (> 80% adherence), and only one minor exercise-related adverse event occurred.ConclusionsPRIDE is the first exercise trial conducted specifically within individuals diagnosed with LBD, and provides important insight for the design of larger, randomized trials for further evaluation of progressive, high-intensity exercise as a valuable treatment in LBD.Trial registrationThe PRIDE trial protocol has previously been prospectively registered (08/04/2016, ANZCTR: ACTRN12616000466448).

Project description:IntroductionNew Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer's Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently and as well as possible at home for longer. This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. The evaluation will test, refine and develop the NIDUS-Family theoretical model, associated causal assumptions and logic model to identify key mechanisms of impact, implementation and contextual factors influencing the intervention's effectiveness. Findings will inform how the programme is implemented in practice.Methods and analysisThe process evaluation will be theory driven and apply a convergent mixed-methods design. Dyads (PLWD and family carer) will be purposively sampled based on high or low Goal Attainment Scaling scores (trial primary outcome). Qualitative interviews with dyads (approx. n=30) and their respective facilitators post-trial will explore their experiences of receiving and delivering the intervention. Interviews will be iteratively thematically analysed. Matching observational quantitative data will be collected concurrently from videorecordings and/or audiorecordings of NIDUS-Family dyad trial sessions. Further quantitative data will be collected through an acceptability questionnaire for all intervention-arm dyads (n=199). Mixed-method integration will use an interactive analysis strategy, considering qualitative and quantitative findings through mixed-method matrix for dyadic level 'case studies', and a joint display for 'population' level analysis and interpretation.Ethics and disseminationEthical approval was received from Camden & Kings Cross Research Ethics Committee (REC). Study reference: 19/LO/1667. IRAS project ID: 271 363. This work is carried out within the UCL Alzheimer's Society Centre of Excellence (grant 300) for Independence at home, NIDUS programme.Findings will be disseminated through publications and conferences, and as recommendations for the implementation study and strategy.Trial registration numberISRCTN11425138.

Project description:BackgroundPeople with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness.MethodsWe will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants' homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective.DiscussionWe describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia.Trial registrationISRCTN, ISRCTN15320670. Registered on 4 September 2018.

Project description:IntroductionMany people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention.Methods and analysisA feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents' activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers.Ethics and disseminationThis protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications.Trial registration numberISRCTN14948133; Pre-results.

Project description:IntroductionIndividuals with dementia face an increased risk of falls. Falls can cause a decline in the individual's overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia.Method and analysisThis is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes.Ethics and disseminationThe study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals.Trial registration numberISRCTN16413728.

Project description:The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).Adolescents aged 12-18 with low mood/depression, (scoring ?20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).ISRCTN31219579.

Project description:IntroductionThere are 3.9 million people in the UK with diabetes. Sarcopenia, increased frailty and loss of independence are often unappreciated complications of diabetes. Resistance exercise shows promise in reducing these complications in older adult diabetes patients. The aim of this feasibility randomised controlled trial is to (1) characterise the physical function, cardiovascular health and the health and well-being of older adults with mild frailty with/without diabetes treated with insulin, (2) to understand the feasibility and acceptability of a 4-week resistance exercise training programme in improving these parameters for those with diabetes and (3) to test the feasibility of recruiting and randomising the diabetic participant group to a trial of resistance training.Methods and analysisThirty adults aged ≥60 years with insulin-treated diabetes mellitus (type 1 or 2), and 30 without, all with mild frailty (3-4 on the Rockwood Frailty Scale) will be recruited. All will complete blood, cardiovascular and physical function testing. Only the diabetic group will then proceed into the trial itself. They will be randomised 1:1 to a 4-week semisupervised resistance training programme, designed to increase muscle mass and strength, or to usual care, defined as their regular physical activity, for 4 weeks. This group will then repeat testing. Primary outcomes include recruitment rate, attrition rate, intervention fidelity and acceptability, and adherence to the training programme. A subset of participants will be interviewed before and after the training programme to understand experiences of resistance training, impact on health and living with diabetes (where relevant) as they have aged. Analyses will include descriptive statistics and qualitative thematic analysis.Ethics and disseminationThe North East-Newcastle and North Tyneside 2 Research Ethics Committee (20/NE/0178) approved the study. Outputs will include feasibility data to support funding applications for a future definitive trial, conference and patient and public involvement presentations, and peer-reviewed publications.Trial registration numberISRCTN13193281.

Dataset Information

Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.

Publications

Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.

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